Swissmedic Publishes swissdamed Business Rules Version 4.0
Swissmedic has released Version 4.0 of the swissdamed Business Rules document, effective from 2 June 2026. The update introduces several new business rules and clarifications affecting device registration and UDI management within Switzerland’s medical device database.
The revised document includes updates to existing rules and introduces several new requirements, particularly in relation to Master UDI-DIs, data management, and device registration processes.
Key Changes
New Requirements for Master UDI-DIs
Swissmedic has introduced new rules regarding Master UDI-DIs, including:
A mandatory special device type for Master UDI-DIs, covering categories such as contact lenses, spectacle frames, spectacle lenses, and ready-made reading spectacles.
New restrictions specifying that Unit of Use DI, Direct Marking DI, related device references, and “new device” attributes cannot be provided when registering a Master UDI-DI.
Recognition of GS1, HIBCC, and IFA as issuing entities for Master UDI-DIs.
Additional Data Governance Rules
The update introduces a new rule clarifying that Package UDI-DIs linked to Master UDI-DI devices can only be associated with a Master UDI-DI identifier.
Swissmedic has also clarified several non-updatable fields for both UDI-DIs and Basic UDI-DIs, reinforcing data integrity once records have been registered.
Clarifications for Legacy Devices
Version 4.0 further refines the handling of legacy devices, including limitations on data elements that may be submitted for devices under MDD, AIMDD, and IVDD legislation.
The document also reiterates that certain legacy devices requiring a Master UDI-DI under MDR cannot be uploaded to swissdamed.
What This Means for Manufacturers
Manufacturers placing devices on the Swiss market should review the updated business rules, particularly if they:
Register devices requiring a Master UDI-DI.
Manage product portfolios containing legacy devices.
Use automated UDI data submission processes.
Plan future updates to existing swissdamed registrations.
The introduction of additional validation rules and restrictions on editable fields means that manufacturers should ensure device data is complete and accurate before submission, as some attributes cannot be modified once registered.
Manufacturers should also assess whether any products fall within the newly defined Master UDI-DI categories and confirm that their identification and registration processes align with the updated requirements.
The updated swissdamed Business Rules (Version 4.0) entered into force on 2 June 2026.
